STUDY OF SAFETY AND EFFICACY OF THE COMBINATION OF AMITRIPTYLINE AND PREGABALIN SR IN SEVERE NEUROPATHIC PAIN: DATA OF LOGIC TRIAL

Abstract

Objective: To evaluate the safety and efficacy of the combination of amitriptyline and pregabalin SR in patients of severe neuropathic pain not controlled on monotherapy of a neuroanalgesic.

Methods: LOGIC Study was conducted at 120 centres on 1269 patients across India. Patients above 18 years with severe neuropathic pain not controlled on monotherapy of a neuroanalgesic and who satisfied the inclusion and exclusion criteria were enrolled in the study. A combination of amitriptyline and pregabalin SR was given once daily. Patients were evaluated for the efficacy by visual analogue scale (VAS). Safety was evaluated through the noting adverse events occurring during the study. Patients VAS score were noted at baseline(visit 1), day 7(visit 2), day 21(visit 3) and also asked for any adverse events. Change in mean VAS score, percentage of patients achieving ?50% reduction in pain at every visit and Number Needed to Treat (NNT) was assessed.

Results: Mean VAS score was 7.87 at baseline, 5.6 at day 7 and 3.42 at day 21. 46.4% and 84.6% of total patients at day 7 and 21 respectively had a reduction in pain of ?50% from the baseline. NNT was calculated to be 1.19 for achieving ?50% pain relief. Reduction in pain intensity was irrespective of blood glucose control, age and gender of the patient. Adverse effects were observed in 15% patients of patients – Sedation, Dizziness, Dry Mouth and Constipation were predominant.

Conclusion: Combination of amitriptyline and pregabalin SR is safe and efficacious in the treatment of severe neuropathic pain.

Keywords: Amitriptyline, Pregabalin, Severe Neuropathic Pain, NNT.